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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. ELECTRODE, PACEMAKER, TEMPORARY

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MEDTRONIC, INC. ELECTRODE, PACEMAKER, TEMPORARY Back to Search Results
Model Number 5833SL
Device Problem Device Operates Differently Than Expected
Event Date 01/24/2017
Event Type  Malfunction  
Manufacturer Narrative

Product event summary: analysis could not confirm the reported issue. The cable passed all incoming visual inspections, and all continuity tests passed. No intermittent or shorted connections were found.

 
Event Description

It was reported implantable lead diagnostic tests could not be performed. The lead was discarded and replaced with a new lead and the same issue occurred with the new lead. The surgical cable was replaced and the normal lead tests could be performed. The surgical cable has been returned. No patient complications have been reported as a result of this event.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
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Brand NameNA
Type of DeviceELECTRODE, PACEMAKER, TEMPORARY
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view , MN 55112
7635052036
MDR Report Key6468085
Report Number2182208-2017-00503
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 01/25/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/06/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number5833SL
Device Catalogue Number5833SL
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/22/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2017
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 04/06/2017 Patient Sequence Number: 1
Treatment
5076-58 LEAD
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